BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK MEDICAL PNEUMOTHORAX SET

    MDR report key: 1963476 · Received January 14, 2011

    Report

    Report Number
    1963476
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    January 11, 2011
    Manufacturer
    COOK INCORPORATED
    Product Code
    BYY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CHEST TUBE PLACED ON (B)(6) 2011 FOR PNEUMO THORAX (AFTER LUNG BIOPSY ON (B)(6)-2011) - PROCEDURE PERFORMED BY IR PHYSICIAN; THE HEIMLICH VALVE WAS PLACED ON THE CHEST TUBE; POST-PROCEDURE, SCAN DEMONSTRATES IMPROVEMENT IN PNEUMOTHORAX. THE PT DEVELOPED SUBCUTANEOUS AIR ON RIGHT CHEST TO RADIOLOGY - CT PERFORMED & NOTED LARGE PNEUMOTHORAX - AT TIME PT SEEN IN RADIOLOGY, THE VALVE ON THE TUBING WAS CONNECTED BACKWARDS - UNCLEAR HOW THIS OCCURRED - UPON CLOSE INSPECTION, THERE IS A CLEAR ARROW DENOTING, DIRECTION OF FLOW BUT THIS INFO IS DIFFICULT TO SEE & READ; IF THE TUBING & VALVE CAME APART. IT WOULD BE DIFFICULT TO KNOW THAT THE VALVE WAS TO BE PLACED IN A SPECIFIC DIRECTION; ASSURES THAT THIS IS WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK MEDICAL PNEUMOTHORAX SET VALVE FOR CHEST TUBE SET BYY COOK INCORPORATED C-TPT-100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R